Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and
FDA device recall Z-0452-2008 · posted 2007-12-11 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal
- Action taken
- Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 11,319 cases (476,160 units)
- Distribution
- Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saud
- Date initiated
- 2007-11-02
- Date posted
- 2007-12-11
- Date terminated
- 2010-03-31
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX (K991855) | Conmedcorp | 1999-06-15 |
| ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE (K935091) | Conmedcorp | 1994-02-28 |